Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM
ConditionHouse Dust Mite Allergy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorProbelte Pharma S.L.U.
About this trial
The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma
Eligibility criteria
Qualifiers
Written informed consent, signed and duly dated.
Man or woman between 12 and 65 years old (both included).
Patient with moderate or severe symptoms of persistent rhinitis according to the ARIA Guide, associated or not with well or partially controlled asthma according to the GEMA 5.0 Guide.
Confirmation of sensitization to DPT or DF with a positive prick test (mean papule diameter greater than or equal to 3 mm) with a commercial standardized allergenic extract and a serum extract-specific IgE value of class 3 or higher (> 3.5 kU / L) within the 6 months prior to the study.
Disqualifiers
Concomitant sensitization to allergens other than dust mites if clinically relevant symptoms are anticipated that may interfere with study evaluation periods at the discretion of the investigator.
Poorly controlled asthma according to the GEMA 5.0 guideline
Severe asthma, that is, those who during the last months have controlled their asthma according to therapeutic step 5-6 of the GEMA 5.0 guideline.
Autoimmune diseases or immunodeficiency.
Trial design
Treatments tested in this trial
- House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae
- Placebo
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov